Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:56 AM
NCT ID: NCT00867334
Description: Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
Frequency Threshold: 0
Time Frame: Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Study: NCT00867334
Study Brief: New Individualized Therapy Trial for Metastatic Colorectal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment With Increasing Doses of Imatinib Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab. All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab. 1 None 2 6 5 6 View
Standard of Care Therapy With Panitumumab Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemorrhage/Bleeding NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash or injection site reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Priuritus/itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage GU - Vaginal NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized aches and pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Creatinine NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alkaline Phosphatase NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferease NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Liver dysfunction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Total Bilirubin NON_SYSTEMATIC_ASSESSMENT General disorders None View
Aspartate aminotransferase NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rigors/chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hepatomegaly NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Absolute neutrophil count NON_SYSTEMATIC_ASSESSMENT General disorders None View
Platelets NON_SYSTEMATIC_ASSESSMENT General disorders None View
Glucose NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anal Incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stool in urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fistula - bladder and rectum NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Albumin NON_SYSTEMATIC_ASSESSMENT General disorders None View
White Blood Count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View